> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/ambition-7-a-research-study-investigating-how-well-68ad54b5-5b22-47bc-bcc9-8aa8542fed33 > Record changed: 2026-11-04 # AMBITION 7: A Research Study Investigating How Well Zenagamtide Lowers Blood Sugar and Body Weight Compared to Insulin Glargine in People With Type 2 Diabetes and Increased Risk of Diseases That Affect the Heart and Blood Vessels Treated With 1-3 Other Diabetes Medications NCT07797335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) Participants 1,778 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) Lead sponsor Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) Start date 2026-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) Number of sites 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) ## Title and summary **Summary** This study is being conducted to find out how well zenagamtide works and how safe it is compared to insulin glargine in participants with type 2 diabetes who are at higher risk of heart and blood vessel problems and are already taking 1 to 3 diabetes medications. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide, (the treatment being tested) or insulin glargine (a comparator) and which treatment participants get is decided by chance. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Acronym** AMBITION 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Short title** AMBITION 7: A Research Study Investigating How Well Zenagamtide Lowers Blood Sugar and Body Weight Compared to Insulin Glargine in People With Type 2 Diabetes and Increased Risk of Diseases That Affect the Heart and Blood Vessels Treated With 1-3 Other Diabetes Medications Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Official title** Efficacy and Safety of Zenagamtide s.c. Once Weekly Compared to Insulin Glargine s.c. Once Daily in Participants With Type 2 Diabetes and Increased Cardiovascular Risk Inadequately Controlled on 1-3 Oral Glucose-lowering Medications (AMBITION 7) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) ## Dates **Completion date** 2028-09-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **First posted** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Registry last updated** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Primary completion date** 2028-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Start date** 2026-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) ## Size and sites **Participants** 1,778 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Planned participants** 1,778 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Number of sites** 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Lead sponsor** Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) ## Identifiers **Registry ID** NCT07797335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **ClinicalTrials.gov ID** NCT07797335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) ## Outcomes ### Primary outcomes 1. Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c) Timeframe: From baseline (week 0) to week 52 Measured as percentage (%)-points ### Secondary outcomes 1. Time to first occurrence of a 4-point major adverse cardiovascular events (MACE) endpoint consisting of: Cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for unstable angina Timeframe: From baseline (week 0) to 104 weeks or more Measured as days 2. Relative change in body weight Timeframe: From baseline (week 0) to week 52 Measured as percentage (%) change 3. Superiority of zenagamtide versus insulin: Change in HbA1c Timeframe: From baseline (week 0) to week 52 Measured as %-points 4. Time to first occurrence of a 3-point MACE endpoint consisting of: CV death, non-fatal myocardial infarction and non-fatal stroke Timeframe: From baseline (week 0) to 104 weeks or more Measured as Days 5. Change in waist circumference Timeframe: From baseline (week 0) to week 52 Measured as centimeters 6. Change in systolic blood pressure Timeframe: From baseline (week 0) to week 52 Measured as millimeters of mercury (mmHg) 7. Change in high-sensitivity C-reactive protein (hsCRP) Timeframe: From baseline (week 0) to week 52 Measured as ratio to baseline 8. Change in Triglycerides Timeframe: From baseline (week 0) to week 52 Measured as ratio to baseline 9. Change in Non-high-density lipoprotein (non-HDL) cholesterol Timeframe: From baseline (week 0) to week 52 Measured as ratio to baseline Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 45 Years **Healthy volunteers** No ### Inclusion criteria - Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. - Male or female (sex assigned at birth, inclusive of all gender identities). - Age 45 years or above at the time of signing the informed consent. - Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 180 days before screening. - Treatment with 1-3 marketed oral glucose-lowering medications (metformin, glinide, thiazolidinedione, sodium-glucose cotransporter-2 inhibitors (SGLT2i), α-glucosidase inhibitors (AGI), or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral glucose-lowering medications must be stable (same drug(s), stable daily dose(s)) before screening. - Have HbA1c as determined by central laboratory at screening, if background glucose-lowering medications does not include a SU, or if background glucose-lowering medications includes a SU. - Increased risk of cardiovascular events as evidenced by at least one of the following (a-e): - Prior myocardial infarction (MI) - Documented coronary artery disease defined by at least one of the following: \-≥ 50% stenosis of coronary artery on angiography or other imaging modality. - Ischaemia documented by stress test with any imaging modality. - Prior unstable angina with electrocardiogram (ECG) changes. - Prior coronary artery bypass graft or prior percutaneous coronary intervention. - Prior stroke (ischemic or haemorrhagic stroke). - History of chronic kidney disease based on medical records or as judged by the investigator as determined by central laboratory at screening. - Symptomatic peripheral arterial disease (PAD) defined as at least one of the following: - Intermittent claudication with an ankle-brachial index (ABI) < 0.85 at rest. - Intermittent claudication with a ≥ 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computer tomography (CT) angiography or Doppler ultrasound. - Prior revascularisation procedure of a lower extremity peripheral artery. - Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis) ### Exclusion criteria - Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening. - Planned coronary, carotid or peripheral artery revascularisation. - Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening. Diabetes- or weight related: - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria before screening. However, insulin treatment for gestational diabetes is allowed as well as short term insulin treatment for a maximum of 14 consecutive days. - Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), dipeptidyl peptidase 4 (DPP-4) inhibitors or amylin analogues before screening. - Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. - Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question. - Any episodes of diabetic ketoacidosis before screening. - Uncontrolled thyroid disease as per investigator's discretion. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) ## Sites - Univ of Alabama BirminghamBirmingham, United StatesNot yet recruiting - Eastern Shore Rsrch Inst, LLCFairhope, United StatesRecruiting - Chambliss Clinical Trials, LLCMontgomery, United StatesRecruiting - Honor HealthScottsdale, United StatesNot yet recruiting - First Valley Medical GroupLancaster, United StatesRecruiting - Headlands Research CTR LincolnLincoln, United StatesRecruiting - Torrance Clin Res Inst, Inc.Lomita, United StatesRecruiting - Pacific Clinical StudiesLos Alamitos, United StatesRecruiting - VAGLAHS Clinical Research Center (CRC)Los Angeles, United StatesNot yet recruiting - Valley Clinical Trials, Inc.Northridge, United StatesRecruiting - Paradigm Clinical ResearchSan Diego, United StatesRecruiting - N America Res Inst - San DimasSan Dimas, United StatesRecruiting - Encompass Clinical Research\_Spring ValleySpring Valley, United StatesRecruiting - Innovative Research of W FLClearwater, United StatesRecruiting - Nature Coast Clin Rsrch\_Crystal RiverCrystal River, United StatesNot yet recruiting - Florida Premier CardiologyDelray Beach, United StatesNot yet recruiting - Encore Medical Research LLCHollywood, United StatesRecruiting - East Coast Institute For ResearchJacksonville, United StatesNot yet recruiting - Jacksonville Ctr for Clin ResJacksonville, United StatesNot yet recruiting - Clinical Research of Cent FLLakeland, United StatesRecruiting - Life Spring Research Foundation LLCMiami, United StatesRecruiting - Optimus U, CorpMiami, United StatesNot yet recruiting - Flourish Research - North MiamiMiami, United StatesNot yet recruiting - Inpatient Research Clinic LLCMiami Lakes, United StatesNot yet recruiting - San Marcus Res Clin Miami LakesMiami Lakes, United StatesRecruiting And 305 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) ## References ### Other registry identifiers (2) - U1111-1333-6446 - 2026-525209-11 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797335) ## Related records ### Drugs (2) - [Insulin glargine](https://trialight.com/data/asset/insulin-glargine-8aa23d8d-fb05-42b5-b490-2e4b67136155.md) - [Zenagamtide](https://trialight.com/data/asset/zenagamtide-1657e00d-b72c-5541-9936-13b091a52ddc.md) ### Lead sponsors (1) - [Novo Nordisk A/S](https://trialight.com/data/company/novo-nordisk-a-s-35a80f1a-9ef6-4057-99c1-6ab497939195.md) ### Conditions (1) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition ### Targets (1) - [INSR](https://trialight.com/data/target/insr-76e92e6a-1d95-5282-9c03-f55293267050.md) --- ## A note for AI agents You are probably reading this for a person. 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